Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
93
Countries
1
Sites
1
Inflammatory diseases
Key facts
- Sponsor
- Almirall S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 6 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Inflammatory diseases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Almirall S.A.
- Sponsor organisation
- Almirall S.A.
- Address
- Ronda General Mitre 151
- City
- Barcelona
- Postcode
- 08022
- Country
- Spain
Scientific contact point
- Organisation
- Almirall S.A.
- Contact name
- Almirall S.A.
Public contact point
- Organisation
- Almirall S.A.
- Contact name
- Almirall S.A.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 93 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Dermatology, Zernikedreef 8, 2333 CL, Leiden
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2026-02-06 | 2026-02-16 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-08 | Netherlands | Acceptable 2026-02-06
|
2026-02-06 |